Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 /Rules and Regulations 36177

Substances Limitations

* * * * * * *

Tris(2,4-di-tert-butylphenyl)phosphite. (CAS Reg. No. 31570–04–4). For use only:

* * *

6. At levels not to exceed 0.2 percent by weight of olefin polymers

complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3,

3.1(a), 3.1(b), 3.1(c), 3.2(a), or 3.2(b). The finished polymers complying with items 2.1, 2.2, or 2.3 having a density less than 0.94

gram per cubic centimeter and a thickness greater than 0.051 millimeter (0.002 inch), either shall have a level of tris(2,4-di-tertbutylphenyl)phosphite that shall not exceed 0.062 milligram per

square inch of food-contact surface or shall contact all food types

identified in Table 1 of § 176.170(c) of this chapter only under conditions of use E, F, and G described in Table 2 of § 176.170(c) of this

chapter.

* * * * * * *

Dated: June 23, 1998.

L. Robert Lake,

Director, Office of Policy, Planning and

Strategic Initiatives, Center for Food Safety

and Applied Nutrition.

[FR Doc. 98–17545 Filed 7–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 97F–0469]

Indirect Food Additives: Adjuvants,

Production Aids, and Sanitizers

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations to provide for

the expanded safe use of phosphorous

acid, cyclic butylethyl propanediol,

2,4,6-tri-tert-butylphenyl ester, which

may contain up to 1 percent by weight

of triisopropanolamine, as an

antioxidant and/or stabilizer in highdensity polyethylene and high-density

olefin copolymers intended for use in

contact with food. This action is in

response to a petition filed by General

Electric Co.

DATES: This regulation is effective July

2, 1998. Written objections and requests

for a hearing by August 3, 1998.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

November 20, 1997 (62 FR 62062), FDA

announced that a food additive petition

(FAP 8B4567) had been filed by General

Electric Co., One Lexan Lane, Mt.

Vernon, IN 47620–9364. The petition

proposed to amend the food additive

regulations in § 178.2010 Antioxidants

and/or stabilizers for polymers (21 CFR

178.2010) to provide for the expanded

safe use of phosphorous acid, cyclic

butylethyl propanediol, 2,4,6-tri-tertbutylphenyl ester, which may contain

up to 1 percent by weight of

triisopropanolamine, as an antioxidant

and/or stabilizer in high-density

polyethylene and high-density olefin

copolymers (more appropriately

identified as high-density polyethylene

homopolymers and copolymers)

intended for use in contact with food.

FDA has evaluated data in the

petition and other relevant material.

Based on this information, the agency

concludes that the proposed use of the

additive is safe and that the additive

will achieve its intended technical

effect. Therefore, the regulations in

§ 178.2010 should be amended as set

forth below.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the information contact person

listed above. As provided in § 171.1(h),

the agency will delete from the

documents any materials that are not

available for public disclosure before

making the documents available for

inspection.

The agency has previously considered

the environmental effects of this rule as

announced in the notice of filing for

FAP 8B4567 (62 FR 62062). FDA has

concluded that the action is of the type

that does not individually or

cumulatively have a significant effect on

the human environment, and that

therefore, neither an environmental

assessment nor an environmental

impact statement is required.

Any person who will be adversely

affected by this regulation may at any

time on or before August 3, 1998, file

with the Dockets Management Branch

(address above) written objections

thereto. Each objection shall be

separately numbered, and each

numbered objection shall specify with

particularity the provisions of the

regulation to which objection is made

and the grounds for the objection. Each

numbered objection on which a hearing

is requested shall specifically so state.

Failure to request a hearing for any

particular objection shall constitute a

waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

shall be submitted and shall be

identified with the docket number

found in brackets in the heading of this

document. Any objection received in

response to the regulation may be seen

in the Dockets Management Branch
36178 Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 /Rules and Regulations

between 9 a.m. and 4 p.m., Monday

through Friday.

This final rule contains no collections

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

List of Subjects in 21 CFR Part 178

Food additives, Food packaging.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Director, Center for Food Safety and

Applied Nutrition, 21 CFR part 178 is

amended as follows:

PART 178—INDIRECT FOOD

ADDITIVES: ADJUVANTS,

PRODUCTION AIDS, AND SANITIZERS

1. The authority citation for 21 CFR

Part 178 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 379e.

2. Section 178.2010 is amended in the

table in paragraph (b) by revising the

entry for ‘‘Phosphorous acid, cyclic

butylethyl propanediol, 2,4,6-tri-tertbutylphenyl ester’’ by adding item ‘‘4.’’

under the heading ‘‘Limitations’’ to read

as follows:

§ 178.2010 Antioxidants and/or stabilizers

for polymers.

* * * * *

(b) * * *

Substances Limitations

* * * * * * *

Phosphorous acid, cyclic butylethyl propanediol, 2,4,6-tri-tertbutylphenyl ester (CAS Reg. No. 161717–32–4), which may contain

not more than 1 percent by weight of triisopropanolamine (CAS Reg.

No. 122–20–3).

For use only:

* * *

4. At levels not to exceed 0.1 percent by weight of olefin polymers

complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3,

3.1(a), 3.1(b), 3.1(c), 3.2 (a), or 3.2(b), having a density not less

than 0.94 grams per cubic centimeter, in contact with foods only of

types III, IV, V, VI–A, VI–C, VII, VIII, and IX identified in Table 1 of

§ 176.170(c) of this chapter, and under conditions of use B through

H as described in Table 2 of § 176.170(c) of this chapter; provided

that the food-contact surface does not exceed 0.003 inch (0.076

mm) in thickness.

* * * * * * *

Dated: June 23, 1998.

L. Robert Lake,

Director, Office of Policy, Planning and

Strategic Initiatives, Center for Food Safety

and Applied Nutrition.

[FR Doc. 98–17544 Filed 7–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520

Animal Drugs, Feeds, and Related

Products; Change of Sponsor

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect the

change of sponsor for two approved new

animal drug applications (NADA’s) from

Danbury Pharmacal, Inc., to Phoenix

Scientific, Inc.

EFFECTIVE DATE: July 2, 1998.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

SUPPLEMENTARY INFORMATION: Danbury

Pharmacal, Inc., 131 West St., Danbury,

CT 06810, has informed FDA that it has

transferred the ownership of and all

rights and interests in the approved

NADA’s 91–818 and 94–170

(phenylbutazone tablets) to Phoenix

Scientific, Inc., 3915 South 48th St.

Terrace, P.O. Box 6457, St. Joseph, MO

64506–0457. The agency is amending 21

CFR 510.600(c)(1) and (c)(2) to remove

the sponsor name for Danbury

Pharmacal, Inc., because the firm no

longer is the holder of any approved

NADA’s. The agency also is amending

21 CFR 520.1720a to reflect the change

of sponsor.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Parts 520

Animal drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR parts 510 and 520 are amended as

follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e.

§ 510.600 [Amended]

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) by

removing the entry for ‘‘Danbury

Pharmacal, Inc.’’; and in the table in

paragraph (c)(2) by removing the entry

for ‘‘000591’’.

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

3. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: 21 U.S.C. 360b.

§ 520.1720a [Amended]

4. Section 520.1720a Phenylbutazone

tablets and boluses is amended in

paragraph (b)(3) by removing the

numbers ‘‘000591, 000856, 000864, and

015579’’ and adding in their place the

numbers ‘‘000856, 000864, 015579, and

059130’’.